Performs and / or coordinates specific tasks and functions within the company’s Quality System areas.
Material quality issues avoidance.
Evaluate quality issues reports in Manufacturing, Quality Assurance Final Inspection and Quality Assurance Laboratories.
Investigate Non-Conforming Reports (NCR), laboratory investigations and complaints.
Prepare rework protocols for NCRs.
Monitors & measures Quality Key Performance Indicators (KPI).
Lead quality improvements projects
Lead CAPA / PA investigation for Quality System issues & improvement.
Support to sterilization process requirements, validation, and parametric release parameters.
Monitors to assure compliance and strengthening of Sterilization Program.
Develops procedures for quality.
Assures compliance with laws & regulations.
Develops & executes engineering studies for new processes / new technology.
Systems & equipment PM’s SOP’s revisions / improvements.
KNOWLEDGE, SKILLS AND ABILITIES
Five years or more of experience in Quality Engineering.
Knowledge of Quality System Regulations, FDA, and ISO, MDSAP, etc.
Excellent oral and written communication skills in both English and Spanish.
Strong experience in Microbiology concepts (i.e. spores, Bioburden, aseptic techniques, contamination control,
Knowledge in Steam Sterilization process (autoclave) Desirable
Strong applied knowledge on statistical tools : DOE, Acceptance Sampling, SPC, etc.
Computer skills (i.e. excel, word, power point, etc ).
Problem solving & continuous improvement skills
Lean Manufacturing knowledge ( desirable)
Willing to Travel
Generally works in a closed environment, in office conditions, with loud level of noise and controllable changes of temperature.
Needs to stand, walk and may be seated for some period of time.
Could be required to travel.
Works with a personal computer and programs to prepare documents or reports.
Applies communication skills (good reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.
Needs to have analytical capacity and level of professionalism and judgment to resolve problems.
Bachelor degree in Science with major in Industrial Engineering, Electric or Electronic Engineer